A Phase 1, Randomized, Blinded, Single-Dose, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Event
研究概览
简要总结
To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734 in adult subjects with type I interferon-mediated autoimmune diseases.
详细描述
MEDI7734 is a human monoclonal antibody that binds to and causes temporary depletion of plasmacytoid dendritic cells (pDCs), a type of white blood cell. The objectives of this study are to evaluate the safety, drug levels, and pDC levels in subjects who are given a single injection of MEDI7734 or a placebo.
The study will be conducted in subjects with at least one of the five following autoimmune diseases: dermatomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus, or systemic sclerosis.
After a screening period, subjects will be randomized in a 3:1 ratio to receive a single dose of MEDI7734 or matching placebo, administered as a subcutaneous (under the skin) injection. After that, subjects will be evaluated periodically at the study site over at least the next 85 days.
Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old
- •Diagnoses of dematomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus and/or systemic sclerosis based on standard criteria.
- •Weight 40-120kg
- •Stable disease such that in the opinion of the investigator it is unlikely that a change in subject's therapeutic regimen would be required during the subsequent 3 months.
排除标准
- •History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
- •Chronic hepatitis B, chronic hepatitis C, or HIV infection.
- •History of latent or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening.
- •Herpes zoster infection within 3 months before randomization
- •Any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide > 20 mg/day, abatacept.
- •Receipt of a mAb within 5 published half-lives prior to Day
- •Receipt of rituximab or an experimental B-cell depleting mAb within 6 months of Day
- •Receipt of rituximab or an experimental B-cell depleting mAb without return of CD19 or CD20 count to above the lower limit of normal.
- •Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, or T-cell vaccination therapy -
研究组 & 干预措施
MEDI7734
Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
干预措施: MEDI7734 (Biological)
Placebo
One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
干预措施: Placebo (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Event
时间窗: Day 85
The safety and tolerability of MEDI7734 as measured by the incidence of any adverse events that occur on or after the day of administration of investigational product through the end of follow-up. Laboratory measurements, vital sign measurements, and electrocardiogram (ECG) parameters will also be evaluated as part of safety.
次要结局
- Pharmacokinetics Tmax(Day 85)
- Anti-drug antibodies(Day 85)
- Pharmacodynamics(Day 85)
- Pharmacokinetics Cmax(Day 85)
- Pharmacokinetic(Day 85)